McLean Luke S, Lim Annette M, Bressel Mathias, Thai Alesha A, Rischin Danny
Department of Medical Oncology, Peter MacCallum Cancer Centre, Melbourne, VIC, Australia.
The Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, VIC, Australia.
Drugs Aging. 2024 Mar;41(3):271-281. doi: 10.1007/s40266-024-01095-z. Epub 2024 Mar 6.
Older patients are often underrepresented in clinical trials owing to exclusionary comorbidities, which are more common with age. Chemotherapy is poorly tolerated in older comorbid advanced cutaneous squamous cell carcinoma (CSCC) patients; however, little is known on the efficacy and tolerability of immune-checkpoint inhibitors (ICIs) in this population. To our knowledge, this is the largest dedicated report on a cohort of older patients with advanced CSCC treated with immunotherapy to date.
The aim was to report outcomes of ICI use in a real-world older cohort with advanced CSCC.
A single-centre retrospective audit of all patients treated via an access scheme providing ICIs to patients with advanced CSCC was conducted. Participants were ≥ 70 years of age and had advanced CSCC not amenable to curative surgery or radiotherapy. Best overall response rate (ORR), 12-month overall survival (OS) and progression-free survival (PFS), and toxicity rates were assessed.
A total of 53 patients were analysed. The median age was 81.8 years (range 70.1-96.8); 81% were male; 34% were immunocompromised; and 34% had an Eastern Cooperative Oncology Group (ECOG) performance status score of ≥ 2. The ORR was 57%, and 12-month OS and PFS were 63% (95% confidence interval [CI] 44-78) and 41% (95% CI 25-57), respectively. Thirty-two per cent developed an immune-related adverse event (irAE), but only two patients experienced a grade 3 irAE, with no treatment-related deaths. Higher ECOG score was associated with worse OS and PFS. No significant association was identified for increasing age, sex, Charlson Comorbidity Index score, or immunocompromised status.
ICIs have demonstrated efficacy and have an acceptable safety profile among older patients with advanced CSCC, with comparable efficacy to what has been demonstrated in current clinical trials.
由于存在排除性合并症，老年患者在临床试验中的代表性往往不足，而合并症随着年龄增长更为常见。老年合并晚期皮肤鳞状细胞癌（CSCC）患者对化疗耐受性差；然而，对于免疫检查点抑制剂（ICI）在该人群中的疗效和耐受性知之甚少。据我们所知，这是迄今为止关于接受免疫治疗的老年晚期CSCC患者队列的最大规模专门报告。
旨在报告ICI在现实世界中老年晚期CSCC队列中的使用结果。
对所有通过为晚期CSCC患者提供ICI的准入计划进行治疗的患者进行单中心回顾性审计。参与者年龄≥70岁，患有无法进行根治性手术或放疗的晚期CSCC。评估最佳总体缓解率（ORR）、12个月总生存期（OS）和无进展生存期（PFS）以及毒性率。
共分析了53例患者。中位年龄为81.8岁（范围70.1 - 96.8）；81%为男性；34%存在免疫功能低下；34%的东部肿瘤协作组（ECOG）体能状态评分为≥2。ORR为57%，12个月OS和PFS分别为63%（95%置信区间[CI] 44 - 78）和41%（95% CI 25 - 57）。32%发生了免疫相关不良事件（irAE），但只有2例患者经历3级irAE，无治疗相关死亡。较高的ECOG评分与较差的OS和PFS相关。未发现年龄增加、性别、Charlson合并症指数评分或免疫功能低下状态之间存在显著关联。
ICI在老年晚期CSCC患者中已显示出疗效且安全性可接受，其疗效与当前临床试验中所证明的相当。
